Clinical trial · Interventional
Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer
Neoadjuvant Hormonal Ablation, Imatinib Mesylate and Docetaxel Followed by Radical Prostatectomy for High-Risk Localized Prostate Cancer
NCT00500110CI-TRIAL-00017662completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objective: 1\. To evaluate the pathological complete response rate to neoadjuvant hormonal ablation, Imatinib and Docetaxel (HID) in high-risk localized prostate cancer. Secondary Objectives: 1. To describe the time to prostate specific antigen (PSA)-progression after neoadjuvant HID and radical prostatectomy in high-risk localized prostate cancer. 2. To correlate pathological response with modulation of the Platelet-Derived Growth Factor Receptor (PDGFR) pathway.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Goserelin Acetate | Drug | Goserelin | ALIAS |
| Imatinib Mesylate | Drug | Imatinib Mesylate | ALIAS |
| Leuprolide | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hormonal Ablation, Imatinib + Docetaxel
- description
- Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m\^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
- interventionNames
- Drug: Docetaxel
- Drug: Imatinib Mesylate
- Drug: Leuprolide
- Drug: Goserelin Acetate
Primary outcomes (1)
- measure
- Number of Participants Achieving Pathological Complete Response
- timeFrame
- Every 3 months for 1 year, then every 6 months until disease progression or death
- description
- Probability of response, defined as pathological complete remission based on tissue obtained at surgery. Pathological Complete Response (pCR): Patients without gross or microscopic evidence of residual disease at Radical Prostatectomy defined as pCR.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Patients with adenocarcinoma of the prostate that in the opinion of the surgeon is resectable. Ductal adenocarcinoma of the prostate is included. * All patients must be regarded as low anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy. * All patients must have at least one of the following high-risk features: clinical or pathological T3 disease, or cT2c or PSA\>20ng/ml or Gleason 8-10 adenocarcinoma or clinical T2b and PSA\>10ng/ml and Gleason 7 adenocarcinoma. The 1992 AJCC staging system will be followed. * Prior hormonal therapy up to 2 months is permitted; no concurrent ketoconazole is permitted. * Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of \>/= 1,500/mm3 and platelet count of \>/= 100,000/mm3; adequate hepatic function defined with a total bilirubin of \</= 1.5 mg/dl and aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) \</= 2 times the upper limits of normal; adequate renal function defined as serum creatinine clearance \>/= 40 cc/min (measured or calculated). * Patients must sign a written informed consent form prior to treatment. All patients must have a surgical and medical oncology consult prior to signing informed consent. Exclusion Criteria: * Patients with small cell or sarcomatoid prostate cancers are not eligible. * Patients with clinical or radiological evidence of metastatic disease * Prior chemotherapy or experimental agents * Patients with severe intercurrent infection. * Patients with The New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina or myocardial infarction (MI) in the last 6 months. * Contraindications to corticosteroids. * Uncontrolled severe hypertension, uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease or human immunodeficiency virus (HIV) infection. * Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years. * Overt psychosis, mental disability or otherwise incompetent to give informed consent or history of non-compliance.
References
Publications (1)
- RESULTMathew P, Pisters LL, Wood CG, Papadopoulos JN, Williams DL, Thall PF, Wen S, Horne E, Oborn CJ, Langley R, Fidler IJ, Pettaway CA. Neoadjuvant platelet derived growth factor receptor inhibitor therapy combined with docetaxel and androgen ablation for high risk localized prostate cancer. J Urol. 2009 Jan;181(1):81-7; discussion 87. doi: 10.1016/j.juro.2008.09.006. Epub 2008 Nov 13. PMID 19012911